Purpose:To determine if the use of pigments or adding PVP during the fabrication of 1-DAY ACUVUE® DEFINE™ contact lenses impacts open eye corneal swelling.

Methods:A double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using 1-DAY ACUVUE® DEFINE™ (AD), 1-DAY ACUVUE® DEFINE™ with Lacreon® (AL) and 1-DAY ACUVUE® MOIST® (control). Central corneal thickness (CCT) was measured before lens insertion and immediately after lens removal following an 8 ± 1 hour open eye period in one eye, using an optical pachymeter (OP). Corneal thickness in the horizontal meridian was measured along a 10 mm chord in the contralateral eye, using the Visante™ OCT. A test for non-inferiority for each lens relative to the control was carried out for corneal swelling. The corneal endothelial bleb response was measured at baseline and 20 minutes after insertion using a Topcon SP-3000P specular microscope. High contrast VA (HCVA) and subjective grading of limbal and bulbar hyperemia and corneal staining were monitored at each visit.

Conclusions:After 8 ± 1 hours open eye wear, central and peripheral corneal swelling along horizontal meridian with each AD and AL lens were equal to that observed with the control lens. These results confirm that the addition of PVP or pigments to obtain a limbal ring design have no impact on corneal swelling during normal open eye wear.